Lycopene, belonging to the carotenoid family of natural substances is abundant in various fruits and vegetables. The compound as found in nature has a trans/cis ratio of 90:10, is insoluble in water and has a rather limited solubility in oil or fat. Studies have shown that frequent consumption of lycopene is associated with decrease of chronic disorders such as cardiac and circulatory disorders. In addition, it may contribute to prevention of several types of cancers. Its protective function is attributed to the fact that lycopene acts as an effective antioxidant. Its unique intense red color led to its use as a natural food colorant. Lycopene may be obtained, either synthetically (EP 382,067) or extracted from tomatoes (WO 97/48,287) which have a relatively high concentration of lycopene.
However, use of lycopene as a food supplement is associated with several problems. Its solubility profile is problematic, being insoluble in water and only sparingly soluble in oils and fats. In addition, it is easily oxidized. In addition, lycopene exhibits its unique red color only as long as it is dispersed in water and the particles have a size of 1-10 μm, preferably 1-3 μm. Particles of higher dimensions are less effective colorants. Furthermore, upon contact with oil the lycopene particles dissolve imparting an orange to yellow color.
As a result, lycopene is used only in dedicated formulations, where the lycopene is protected from oxidation by certain additives and/or the lycopene is present as finely divided particles. WO 91/06292 and WO 94/19411 describe the grinding of β-carotene achieving a particle size of ca. 2-10 μm. Dry powders containing lycopene for use as water dispersible powders were reported in EP 832569 and WO 98/16204. Stable pulverulent lycopene formulations comprising lycopene having a degree of crystallinity of greater than 20% are disclosed in U.S. Pat. No. 6,235,315. The stability of the pulverulent formulation is augmented by addition of protective colloids, stabilizers and plasticizers. US 2002/0128325 discloses a process for producing powders of stabilized carotenoids, where a carotenoid is dispersed in a solution containing a protective colloid and lactose, and the use of such powders in pharmaceuticals, food and cosmetics.